# QEI: Breast Milk Macronutrients Test System

- Device class: 2; regulation: 21 CFR 862.1493; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 249 days (middle half 191–306)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- DEN180007: Miris Human Milk Analyzer (2018), cited by 2

Source page: https://510kreport.com/product-code/QEI
Data by year (CSV): https://510kreport.com/product-code/QEI.csv